MODERATE RISK Terminated F-1487-2020

"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"

Recalled by Sundial Herbal Products

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Product Details

Product Quantity
Unknown
Product Type
Food
Code Info
Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
Voluntary/Mandated
FDA Mandated

Distribution & Geography

Distribution Pattern
NY
Company Location
Bronx, NY, 10466-5810

Timeline

Report Date
09/09/2020
Recall Initiated
06/30/2020
Classification Date
09/15/2020
Termination Date
10/26/2022

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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